Therapie最新文献

{"title":"The French Addictovigilance Network - A multidisciplinary successful journey in the protection of public health.","authors":"Ana Carmona Araújo","doi":"10.1016/j.therap.2024.11.009","DOIUrl":"https://doi.org/10.1016/j.therap.2024.11.009","url":null,"abstract":"<p><p>Since the beginning of the century, the USA have been experiencing an opioid epidemic characterised by high levels of prescription opioid use. While extensive North American literature on the topic has been published and several public health measures implemented attempting to address the problem, in Europe addiction research, especially literature focusing on misuse of medicines, lags far behind. France is an exception: it is the only European country that has established a nationwide specific system to monitor misuse of legal and illegal psychoactive substances, an activity that has been named addictovigilance. Thanks to the combined use of several data sources, the French addictovigilance system has, in its three decades of existence, proven to be effective in the early identification and assessment of addictovigilance signals, providing real-world evidence to support the conception and monitoring of public health measures to minimise the health risks posed by psychoactive substance misuse in France.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142855209","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ethics and clinical research: How can the Ethics Committees (CPPs) and Committees for Research Ethics (CER) evolve?","authors":"Driss Berdaï, Aurélie Guérin, David Pérol, Cécile Girault, Mathieu Molimard, Philippe Amiel, Hélène Beaussier, Pierre-Henri Bertoye, Catherine Cornu, Dominique Deplanque, Didier Dreyfuss, Luc Duchossoy, Cécile Fouret, Thibaud Haaser, Anne Le Louarn, Soraya Rifai, Jean-Pierre Thierry","doi":"10.1016/j.therap.2024.11.006","DOIUrl":"https://doi.org/10.1016/j.therap.2024.11.006","url":null,"abstract":"<p><p>In line with the spirit of the Giens workshops, this article reports on the recommended evolution of the Ethics Committees (CPPs) and the Committees for Research Ethics (CER) in France. These committees play a crucial role in the ethical evaluation of clinical research projects, a process that has become more complex, particularly in view of recent legislative, regulatory and methodological developments. This reflection highlights the current challenges faced by the CPPs, including the increasing workload, the complexity of the issues to be addressed and the need for better use of their resources. To address this, several recommendations are proposed. These include improving support to sponsors prior to submission, simplifying administrative tasks for CPP members and improving IT tools. The article also highlights the need for continuous evaluation of the activities of the CPPs to contribute to the quality and consistency of their opinions, as well as the importance of making this activity more attractive to qualified professionals, by offering them adequate compensation and professional recognition. For the benefit of all involved in health research, there is a strong desire to develop a single document management system accessible to all and inclusive of relevant information and document templates. Regarding the CERs, which currently operate without a legal framework, the proposition is that their development should take place under conditions of compliance with essential principles of collegiality, transparency and appropriate management of conflict of interest. Finally, it appeared necessary that the National Commission for Research Involving the Human Person (CNRIPH) be given adequate resources to carry out its tasks effectively, including the coordination of the CPPs and the development of appropriate training programs for their members. These recommendations aim to improve the operating conditions of the CPPs and CERs, ensuring the ethics of the research undertaken, as well as the quality of their results.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"How can the reform of the activity-based payment system (T2A) help in financing innovative health products?","authors":"Xavier Armoiry, Nejma Saidani, Martine Aoustin, Dorothée Camus, Auriane Cano-Chancel, Sophie Carlier, Albane Degrassat-Théas, Anne-Aurélie Epis de Fleurian, Anne Grumblat, Aurélie Lavorel, Mégane Lesaignoux, Tess Martin, Adrien Michaud, Jonathan Morizot, Nathalie Préaubert, Valery-Pierre Riche, Isabelle Durand Zaleski","doi":"10.1016/j.therap.2024.10.063","DOIUrl":"https://doi.org/10.1016/j.therap.2024.10.063","url":null,"abstract":"<p><p>In France, the short-stay activities of public and private sector healthcare facilities have been financed since 2004 by activity-based pricing (T2A). The principle is to allow for payment determined primarily by the nature and volume of activities. T2A has enabled a major transformation compared to the old financing system, chiefly for public sector facilities that used to operate under a general allocation, and convergence between payment methods in the public and private sectors. However, official reports and public pronouncements by many hospital healthcare stakeholders have also highlighted the limits of this method of financing, leading to several reform projects. With that in mind, round table 3 of the Giens Workshops, including experts from academia and/or hospitals, institutions, and industry, questioned the impact of the new T2A reforms on access to innovative health care products in hospitals. After scoping out the issue and drawing up observations, the round table proposed six general recommendations that would be avenues for improving access to innovative health care products for hospital service users.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877913","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Monitoring opioid analgesic misuse, abuse and dependence: What to the data from addictovigilance tell us about the situation in France?","authors":"Maryse Lapeyre-Mestre, Celian Bertin, Constança Jalles, Thomas Soeiro, Joëlle Micallef, Anne Roussin","doi":"10.1016/j.therap.2024.11.008","DOIUrl":"https://doi.org/10.1016/j.therap.2024.11.008","url":null,"abstract":"<p><p>The opioid epidemic has emerged in the USA in the late 1990s and widespread to Canada, Australia, and the UK to a lesser extent in the more recent years. At the European level, several studies performed in different European countries have highlighted that prescription opioid use increased substantially over the last decade, and several proxies for misuse show a parallel increasing trend. The French addictovigilance experience on opioid analgesics is a good example of a specific dedicated monitoring, taking into account in a global and multisource perspective, patterns of utilization, population involved in problematic use, ways of acquisition and health complications. The added value of this data triangulation is illustrated by the recent data on tramadol and oxycodone. The addictovigilance monitoring is particularly relevant to identify early signals of potential problematic use and to assess the impact of campaigns for opioid analgesics rational use and regulatory changes.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877918","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Acute cytolytic hepatitis followed by edema associated with the use of antipsychotics neuroleptics: A case report and review of the literature].","authors":"Fatma Guermazi, Rabeb Jbir, Imen Bouaziz, Rim Atheymen, Dorra Mnif, Nourelhouda Ben Ali, Kamilia Ksouda, Khaled Zghal, Imen Baati, Jawaher Masmoudi","doi":"10.1016/j.therap.2024.11.004","DOIUrl":"https://doi.org/10.1016/j.therap.2024.11.004","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-11-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142814231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Oxybutynin induced blindness in a child: Case report.","authors":"Mouna Daldoul, Ahmed Zaiem, Yasmine Salem Mahjoubi, Ons Charfi, Ghozlane Lakhoua, Sarrah Kastalli, Riadh Daghfous, Imen Aouinti, Sihem El Aidli","doi":"10.1016/j.therap.2024.11.003","DOIUrl":"https://doi.org/10.1016/j.therap.2024.11.003","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142814233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The enhanced national pharmacovigilance system implemented for COVID-19 vaccines in France: A 2-year experience report.","authors":"Samuel Crommelynck, Aurélie Grandvuillemin, Claire Ferard, Céline Mounier, Nathalie Gault, Evelyne Pierron, Baptiste Jacquot, Tiphaine Vaillant, Isabelle Parent du Chatelet, Alexis Jacquet, Francesco Salvo, Martine Alt, Haleh Bagheri, Joëlle Micallef, Antoine Pariente, Sophie Gautier, Marie-Blanche Valnet-Rabier, Marina Atzenhoffer, Marion Lepelley, Judith Cottin, Isabelle Lacroix, Valérie Gras, Nathalie Massy, Alban Dhanani, Philippe Vella, Youssef Shaim, Laurence Baril, Annie-Pierre Jonville-Béra, Mehdi Benkebil","doi":"10.1016/j.therap.2024.11.002","DOIUrl":"https://doi.org/10.1016/j.therap.2024.11.002","url":null,"abstract":"<p><p>In March 2020, World Health Organization recognized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emergence as a public health emergency of international concern. One of the major preventative measures developed against coronavirus disease 2019 (COVID-19) was vaccines. To monitor their use and safety of vaccines from the first utilization in humans during clinical development phases to implementation for the general population, an enhanced national pharmacovigilance system was enabled by the French National Agency for Medicines and Health Products Safety in collaboration with the 30 Regional Pharmacovigilance Centres. Here, we review the significant outcomes from a 2-year collaboration experience between the French National Agency for Medicines and Health Products Safety, the 30 Regional Pharmacovigilance Centres, disease-related experts and the pharmacovigilance and risk assessment committee at the European medicine agency. In France, until January 2023, over 155 million doses of COVID-19 vaccines were administrated, and 190,000 adverse events following immunizations (25% classified as serious) were analysed. Altogether 53 potential safety signals were reported to the Pharmacovigilance and Risk Assessment Committee at the European Medicine Agency by the French National Agency for Medicines and Health Products Safety: 13 were confirmed, 24 are still under investigation and 16 were not confirmed. The enhanced national PV system contributed actively better to define the safety profile of the newly developed vaccines, and the French National Agency for Medicines and Health Products Safety continues to monitor the benefit and risks of the COVID-19 vaccines.</p>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142786791","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comment la réforme de la T2A peut-elle permettre de financer des produits de santé innovants ?","authors":"Xavier Armoiry, Nejma Saidani, Martine Aoustin, Dorothée Camus, Auriane Cano-Chancel, Sophie Carlier, Albane Degrassat-Théas, Anne-Aurélie Epis de Fleurian, Anne Grumblat, Aurélie Lavorel, Mégane Lesaignoux, Tess Martin, Adrien Michaud, Jonathan Morizot, Nathalie Préaubert, Valery-Pierre Riche, Isabelle Durand Zaleski","doi":"10.1016/j.therap.2024.11.001","DOIUrl":"https://doi.org/10.1016/j.therap.2024.11.001","url":null,"abstract":"","PeriodicalId":23147,"journal":{"name":"Therapie","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142755627","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Physicians, pharmacists and take-home naloxone: What practices? The SINFONI study","authors":"Mélanie Duval ,&nbsp;Aurélie Aquizerate ,&nbsp;Emmanuelle Jaulin ,&nbsp;Morgane Rousselet ,&nbsp;Emmanuelle Kuhn ,&nbsp;Alain Guilleminot ,&nbsp;Isabelle Nicolleau ,&nbsp;Solen Pele ,&nbsp;Thomas Herault ,&nbsp;Pascal Artarit ,&nbsp;Eleni Soulidou-Jacques ,&nbsp;Edouard-Jules Laforgue ,&nbsp;Caroline Victorri-Vigneau","doi":"10.1016/j.therap.2024.07.001","DOIUrl":"10.1016/j.therap.2024.07.001","url":null,"abstract":"<div><h3>Objective</h3><div>For several years, both the French Addictovigilance Network and French health authorities have consistently emphasized the need to provide opioid users with take-home naloxone (THN), the specific antidote for opioid overdoses. In March 2022, the French Health Authority recommended systematically assessing the appropriateness of prescribing THN to all opioid users, regardless of the context, and identified 8 high-risk situations. However, at present, THN distribution remains limited, particularly among primary care healthcare professionals. This study, conducted by the Pays de la Loire Centre for Evaluation and Information on Drug Dependence-Addictovigilance and supported by the Regional Health Agency, aims to explore healthcare professionals’ practices and perceptions of these high-risk situations.</div></div><div><h3>Methods</h3><div>An ad-hoc questionnaire was distributed via mail by the project's regional institutional partners to the target healthcare professionals: pharmacists, general practitioners (GPs), physicians practicing in specialities other than general medicine (SPs: algologists, psychiatrists and addictologists). It was completed online from 20/10/2022 to 30/12/2022.</div></div><div><h3>Results</h3><div>Out of the 355 participants (158 pharmacists, 167 GPs and 30 SPs), nearly all were managing patients on opioids. In total, 47.7% of physicians and 27.8% of pharmacists reported experiencing difficulties in dealing with the risk of overdose when prescribing or dispensing opioids to their patients. In the 12<!--> <!-->months preceding the study, only 8 pharmacists and 34 physicians had prescribed/dispensed THN, primarily due to a lack of awareness of its existence (52% of pharmacists and 72% of physicians) and challenges in addressing the eight overdose risk situations listed by the HAS (ranging from 54% to 83% for all professionals). The best-trained healthcare professionals were those who prescribed the most THN (<em>P</em> <!-->&lt;<!--> <!-->0.001).</div></div><div><h3>Conclusion</h3><div>The identification of barriers related to THN distribution in the regional SINFONI study, conducted among primary care healthcare professionals managing patients on opioids, highlights the need to develop a training tool specifically tailored for these professionals.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 6","pages":"Pages 623-633"},"PeriodicalIF":2.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141715325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exposure assessment of titanium dioxide via drugs available on the French market: A nationwide descriptive study","authors":"Manon Cairat ,&nbsp;Inge Huybrechts ,&nbsp;Agnès Fournier","doi":"10.1016/j.therap.2024.07.005","DOIUrl":"10.1016/j.therap.2024.07.005","url":null,"abstract":"<div><h3>Purpose</h3><div>Based on potential adverse health effects including genotoxicity concerns, the European Union banned titanium dioxide (TiO₂) as a food additive in 2022, but food-grade TiO₂ can still be used in pharmaceutical products.</div></div><div><h3>Methods</h3><div>This study described the presence of TiO₂ in drugs available on the French market and estimated the population exposure to TiO₂ through drug consumption. We used annual drug claim data aggregated at the national level together with data on the TiO₂ content of pharmaceutical products available on the French market in 2001–2020.</div></div><div><h3>Results</h3><div>Of the 17 171 pharmaceutical specialties identified on the French market between 2001 and 2020, 38% contained TiO₂. That figure reached 95% for capsules, 92% for film-coated tablets, 74% for coated tablets and 66% for soft capsules. Only 1% of non-oral specialties contained TiO₂. The median TiO₂ amount in one common dispensing unit was 1.5<!--> <!-->mg for oral specialties containing TiO₂. We estimated that the mean exposure to TiO₂ per inhabitant through the consumption of reimbursed drugs between 2012 and 2020 was 1.71<!--> <!-->mg per day, with women (1.81<!--> <!-->mg/d) slightly more exposed than men (1.54<!--> <!-->mg/d) and people older than 59 years (4.00<!--> <!-->mg/d) much more exposed than younger people (1.24 and 0.21<!--> <!-->mg/d for 20–59 and<!--> <!-->&lt;<!--> <!-->20 years old individuals, respectively).</div></div><div><h3>Conclusion</h3><div>This study highlights a widespread presence of TiO₂ in drugs on the French market. The health impact of exposure to TiO₂ through drug consumption should be evaluated in future epidemiological studies.</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 6","pages":"Pages 718-729"},"PeriodicalIF":2.2,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142037104","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}